Our client, a global Biopharma company, needed to quickly come up to speed to both ensure compliance and optimize value, by implementing new QRM practices and supporting tools, in an efficient and effective manner.

AGILE ASSESSMENT AND DEVELOPMENT:

TayganPoint assembled a team of domain experts (Clinical Operations, ICH, RBM), program, and change management professionals to assess the current state compliance and areas of opportunity for improvement.

Working with a cross-functional Sponsor team, recommendations and detailed designs were developed around Process Improvements and Enabling Tools, SOP Development, Training and Communication.

An implementation plan allowing for Fit-For-Purpose solution development and rollout to the client’s Americas, Europe, and Asia-Pac regions was developed.

INCEPTION TO EXECUTION IN LESS THAN 12 MONTHS:

Implementation included:

Developing new ways of working with Investigators and CROs in overseeing quality.